Metabolomic Profiling of Erector Spinae Plane Block* for Breast Cancer Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-10-01

Brief Summary

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Worldwide, breast cancer is the most common cancer among women, and its incidence and mortality rates are expected to increase significantly in the next years. It remains a major health problem. There is a vast area on breast cancer and immunity that still needs to be researched. Do anesthetic techniques and medication preferences effect immune responses? If so how they effect breast cancer outcomes is unclear.

On this trial, the investigators are searching anesthetic techniques affect on inflammatory and immune responses.

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Detailed Description

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Breast cancer is the most frequently encountered surgery among all cancer surgeries. Although it is a well known procedure for anesthesiologists, it is still unclear whether anesthesiology effects immune responses. Cancer therapies often use immune therapies such as Bevacizumab (a monoclonal antibody which targets Vascular Endothelial Growth Factor), Trastuzumab(a monoclonal antibody for Herceptin (HER2/Neu) mutation) how anesthetics effect VEGF stays unclear.

Opioids are commonly used to provide analgesia for cancer pain, and functional opioid receptors have been identified on natural killer (NK) cells, the lymphocytes responsible for surveillance and elimination of cancer cells.\[4\] Anesthesiologists have well founded concerns about using morphine during cancer surgeries.

Regional anesthetic techniques commonly used on cancer surgeries.The activation of sensory neurons during pain enhances tumor progression and metastatic potential. Regional anesthesia blocks somatic nociception and inhibits sympathetic preganglionic outflow (functional sympathectomy) during surgery. Moreover regional anesthesia, by blocking sympathetic nervous system output, induces a prevalence of parasympathetic tone. Local anesthetics can also modulate autonomic receptors. For these reasons, more studies are needed to investigate the action of regional anesthetic neuromodulation on cancer progression.\[11\]

The Erector Spinae Plane Block (ESP block) is most often performed on thoracic paraspinal levels, causes sympathetic blockage. Sympathetic block has been studied on central neuraxial blocks but the sympathetic block caused by the ESP block and immune responses remain unclear.

Sympathetic block inhibits hyperbolic immune responses after surgery, therefore enhances postoperative rate of acceleration on cytokine levels. The investigators propose that ESP block improves immune responses and improved immune responses have better clinical outcomes for patients with breast cancer. Improved immune responses decrease length of stay (LOS), enhance postoperative recovery, analgesia and quality of life. Therefore allows better patient experience about procedures.

The investigators will take 90 patients who will undergo a breast cancer operation and compare vitals (heart rate, blood pressure, oxygen saturation), Numeric Rating Scales (NRS), Vascular Endothelial Growth Factor (VEGF) responses, systemic immune inflammatory indexes, cortisol levels, CRP and Procalcitonin levels between three groups; opioid analgesia group(group M), ESP block group(group E), non-opioid non-ESP group (group P).

The investigators' main focus is immune alterations after anesthesia techniques. Anesthesiologist keep track of pain scores after surgery. this trials secondary outcome focuses on pain management after surgery.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Morphine

30 patients who received intravenous morphine intraoperatively, without regional block application

Morphine

Intervention Type DRUG

PREOPERATIVE ANALGESIA: None

INTRAOPERATİVE ANALGESIA:

1. Paracetamol 1000 mg IV
2. Morphine 0,1 mg/kg IV

POSTOPERATIVE ANALGESIA IV Morphine Patient-Controlled Analgesia (PCA) Rescue analgesic: IV paracetamol

Erector Spinae Block

30 patients who had preoperative esp block but did not use morphine during or after surgery

Erector Spinae Block

Intervention Type PROCEDURE

PREOPERATIVE ANALGESIA:

Ultrasonography (USG) guided ESP block:T4 spinal level, %0,25 concentration 20 ml, single injection

INTRAOPERATİVE ANALGESIA:

1. Paracetamol 1000 mg IV
2. dexketoprofen 50 mg IV

POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol

Control

30 patients who received multimodal analgesia methods other than ESP block or IV morphine

Control

Intervention Type DRUG

PREOPERATIVE ANALGESIA: none

INTRAOPERATİVE ANALGESIA:

1. Paracetamol 1000 mg IV
2. Dexketoprofen 50 mg IV

POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol

Interventions

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Morphine

PREOPERATIVE ANALGESIA: None

INTRAOPERATİVE ANALGESIA:

1. Paracetamol 1000 mg IV
2. Morphine 0,1 mg/kg IV

POSTOPERATIVE ANALGESIA IV Morphine Patient-Controlled Analgesia (PCA) Rescue analgesic: IV paracetamol

Intervention Type DRUG

Erector Spinae Block

PREOPERATIVE ANALGESIA:

Ultrasonography (USG) guided ESP block:T4 spinal level, %0,25 concentration 20 ml, single injection

INTRAOPERATİVE ANALGESIA:

1. Paracetamol 1000 mg IV
2. dexketoprofen 50 mg IV

POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol

Intervention Type PROCEDURE

Control

PREOPERATIVE ANALGESIA: none

INTRAOPERATİVE ANALGESIA:

1. Paracetamol 1000 mg IV
2. Dexketoprofen 50 mg IV

POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol

Intervention Type DRUG

Other Intervention Names

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Opioid Plane block other

Eligibility Criteria

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Inclusion Criteria

1. Should be female
2. Should be between 18-65 years old
3. Diagnosed with unilateral primary breast cancer
4. Are decided to have mastectomy surgery
5. Stage 1-2 breast cancer (T0-1-2, N0-1, M0)

Exclusion Criteria

1. Being allergic to the anesthetics
2. Previously had breast operation other than diagnostic biopsy
3. Presence of a malignancy history on the other breast
4. Diagnosed with Inflammatory breast cancer
5. Having a risk score of The American Society of Anaesthesiologists (ASA) risk score 3 and above
6. Contraindications for regional block(Allergies for local anesthetics, Anatomic application difficulties, Coagulopathies)
7. Hormone usage
8. NRS score greater than 3 before the operation
9. Opioid or steroid usage before the operation
10. Rheumatologic history
11. Sickness or drug usage that might cause immunosuppression
12. Chemotherapy and/or radiotherapy history
13. Concomitant history of previous malignancy
14. History of Coronary Artery Disease, Peripheral Vascular Disease that may affect VEGF
15. Chronic smoking
16. Chronic obstructive pulmonary disease
17. Presence of infection at the time of surgery
18. Hypothalamus, Pituitary, adrenal gland dysfunction
19. Autoimmune diseases

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No